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January 8, 2014
09:10 EDTKOOLThermogenesis signs direct supply agreement with Cord Blood Registry
ThermoGenesis announced the signing of a five-year agreement to supply Cord Blood Registry, with ThermoGenesis' AutoXpress System, or AXP, cord blood processing system and disposables. The AXP System is a proprietary family of automated devices with companion sterile blood processing disposables for harvesting cord blood stem cells in closed systems. Previously, ThermoGenesis supplied CBR the AXP System indirectly through its North American independent distributor.
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November 20, 2014
06:09 EDTKOOLCesca Therapeutics files IDE application for no-option critical limb ischemia
Cesca Therapeutics has submitted an investigational device exemption application to the FDA for a pivotal multicenter study of the company's SurgWerks-CLI and VXP System for treating advanced stages of no-option lower limb critical limb ischemia. The IDE application is the result of two prior positive pilot and feasibility studies conducted in Italy and India, respectively, and collaborative pre-IDE feedback from the U.S. FDA. The primary endpoint is major amputation free survival at 12 months following enrollment.
November 13, 2014
16:02 EDTKOOLCesca Therapeutics reports Q1 EPS (8c), consensus (7c)
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